Surgical mistakes and surgical quality

Recently, surgical mistakes have been highlighted in the Belgian press because of some “forgotten ” surgical instruments in the abdomen of patients. Fortunately this occurs very rarely. It has been said that more people die every year because of surgical mistakes than by car accidents Google ‘surgical mistakes’ and the problem and the stakeholders become clear. This however is only the tip of the iceberg.

The most frequent problem indeed in surgery is informed consent based upon incomplete information and lack of information concerning surgical quality. For most patients it is not very clear which quality of surgical care will be given this varies from the best available to the current practice, which is the medio legal standard. This can be highlighted by the observation that it takes between 10 and 20 years or longer before innovation is introduced; the slow introduction of laparoscopic surgery is an example of this. This website principal aim therefore is information of the patient.

Surgical quality often is suboptimal

There is no quality control for the individual surgical intervention . National statistics only reveal complications, while it is very hard to demonstrate the eventually underlying mistake. For this reason we published a few years ago the recommendation that systematic videoregistration of complete interventions should be mandatory. Although this would permit evaluation afterwards, videoregistration is strongly opposed for various reasons, medico legal considerations being one of them. One aspect, however should be crystal clear,and that is the the price which cannot be a problem since the cost of a DVD, sufficient for an entire operation is less than 1 euro. As an example, to highlight the advantages of videorecording our recent article concerning ureter surgery, we demonstrated that without videorecording is is impossible to distinguish between mistakes, accidents and complete surgery necessitating an ureter lesions eg when infiltrating endometriosis.

Suboptimal surgical quality has many faces.

Surgery can last much longer than necessary . Besides the consequence That anaesthesia takes longer than necessary and that the costs for society are higher, most importantly, postoperative adhesions will increase leading to infertility, pain and reoperation
Inadequate experience of the surgeon. It was suggested that the patient should be informed about the results and experience of the surgeon, ie when the surgeon is still inhis learning curve or when the surgeon is performing an intervention for the first time . This obviously can be circumvented to some extend by the presence of an experienced surgeon during training of registrars. Laparoscopic surgery, increased this problem, since guidance is more difficult while duration of surgery can increase exponentially.
Unnecessary bleedings, which also will increase postoperative adhesions
Incomplete surgery leading to reinterventions. Especially for deep endometriosis surgery this is a major problem .
Unnecessary bowel resections , zoals which often are performed almost systematically for deep endometriosis without any proven benefit in comparison with a more conservative discoid resection, as highlighted z in a recent systematic review on bowel resections for deep endometriosis and as shown in the recent PhD of Dr Jean Squifflet ( promoter Prof Donnez) at the UCL.
Avoidable damage or unnecessary removal of ovaries. The scope of this problem becomes obvious when it is realised that the prospective reports of surgical groups do not demonstrate a decrease of ovarian reserve after surgery, whereas the IVF groups publish an important decrease in ovarian reserve after previous ovarian surgery 2 years ago. This also was a key topic when receiving the ASRM distinguished surgeon award- in Philadelphia, sugegesting that those performing IVF might have a conflict of interest concerning surgery for which most only have a basic training.
A laparotomy for an intervention that can be performed by laparoscopy and this nothwithstanding the advantages of MIS The magnitude of this problem results clearly from the observation that many of the pioneers in endoscopic surgery since 1996 only performed total laparoscopic hysterectomies or vaginal hysterectomies. This is in sharp contrast with the observation that in 2010 many hystrectomies are still performed by laparotomy in Belgium and in the USA. This moreover highlights that information must have been inadequate otherwise women would not still choose to have a laparotomy. The same holds true for most of the gynaecologic interventions , including oncology where laparotomy is still widely used. We therefore suggest that the pelvic surgeon, as a specific subspecialty in gynaecology, would be preferable instead of promoting gynaecologic oncology as a specific subspecialty.

The indication for surgery was wrong

When the indication for surgery was erroneous, things get worse. This becomes apparent when we consider the live time risk of undergoing an hysterectomy,which varies from Dit komt in gynaecologie 50% (USA) over 35% (Belgie) to 25%(UK) and 17%(Zweden) . Moreover many hystrectomies could be prevented by hysteroscopic surgery or by medical therapy. Also in pelvic floor surgery we should realise that not that many surgeons can perform all techniques varying form vaginal (mesh) surgery, to promontofixatone, paravaginal defect en de laparoscopic Burch.

Surgery was not necessary or could have been avoided.

This happens not only for hysterectomies, or for the removal of ovaries (instead of a cystectomy). Also after a bowel resection for endometriosis, endometriosis is not always confirmed.

Informed consent without adequate information

Information is rarely complete to the extend that the patient can judge about alternative treatments, about the experience and results of a surgeon. It indeed is not standard practice that a patient is told the advantages of a laparoscopic intervention by a gynecologist who does not do laparoscopic surgery.

Prof PR Koninckx

During  an endoscopy meeting in Lisbon the use of robots was extensively discussed and this promted us to write this text.

Laparoscopic surgery really started to be developed at the end of the eighties ie more than 20 years ago. Since then we witnessed its development and the progressive demonstration of its superiority in comparison with open traditional surgery.  Patients indeed have less pain, a shorter hospital stay without a scar while the surgical intervention and the complication rate remain the same.

As milestones in gynaecology we had after minor surgery, the introduction of the hysterectomy in 1990,  endometriosis surgery,  the pelvic floor surgery and promontofixation in the mid 90  followed by lympnode resection.  After 2000 not so much did change change anymore neither concerning surgical techniques nor for equipment. This can best be judged by the live surgeries  performed at the yearly meetings of the ESGE, of the AAGL and at many other dedicated meetings.

Yet the  introduction of  endoscopic surgery into main street gynaecology was much slower.  Many of the endoscopists indeed did their last laparotomy  somewhere in the last century (for me in 1996)  and performed all interventions by laparoscopy, except some extreme cases as hysterectomies for a uterus of more than 2000 grams.  This is in sharp contrast with the overall situation in most countries. In Belgium and Italy and the USA the percentages of total laparoscopic hysterectomies, considerd level I still does not reach 10%. For level II surgeries and certainly for the more advanced level III surgery the figures are even lower.  The best explanation for this is that endoscopic surgery is technically much more difficult than we anticipated 20 years ago and that it requires a long and dedicated training to perform.  In addition it has become obvious that endoscopic surgery cannot be done a little bit : unless doing surgery for at least 1 to 2 days a week the necessary skills will not be developed. In gynaecology this observation is pointing to another major problem : there is not enough surgery available in order to permit every gynaecologist to perform every week 1 day of surgery.

Then the  technology of robotic surgery was developed.  This undoubtedly is beautifil technology with some theoretical advantages as decreasing tremor,  more articulated movements which can be scaled down.  The introduction of robotic surgery to the human however occurred without clinical validation and even today 2010 I am not aware of any proven benefit of robotic surgery in comparison with conventional laparoscopic surgery, not in gynaecology, not in urology nor in any other surgical discipline .  This seems strange when considering the number of robots used in Belgium and in the USA.  Following analysis of robotic surgery we would make the following conclusions

1. We all agree that robotic surgery is not superior nor faster than conventional endoscopic surgery provided the endoscopist is a good endoscopic surgeon.
2. Robotic surgery is much more expensive than conventional laparoscopic surgery considering the price around 2.000.000 €,  the maintenance cost and the material cost of a few thousand € for each intervention.  It seems irrealistic that countries will be able to incorporate this into their public medical expenses.
3. The learning curve of robotic surgery is claimed to be shorter than the learning curve of conventional endoscopic surgery.  Yet no data exist to substantiate this claim.  Doing robotic surgery no doubt is more comfortable for the surgeon who can sit.
4. The complexity of robotic instruments is incompatible with being solid : therefore robotic surgery seem not to be appriopriated for  hysterectomies, especially not for a large uterus nor for larger myoma’s. Also larger sutures as used to close the uterus after larger myomectomies cannot be used.
4.  A new generation of robotic surgeons is emerging who never performed laparoscopic surgery and thus went from laparotomy to robotic surgery.  This I consider a dangerous situation, since these surgeons will be unable to deal with eventual complications. They will have to do a laparotomy which means at best a crucial loss of time.

In conclusion,  while being beautiful technology which merits scientific validation (in animals)  robotic surgery today  is not superior to conventional endoscopic surgery for all indications are am aware of.  Its use seem to be limited to those who are unable or unwilling to make the effort of becoming an endoscopic surgeon.  The new generation of robotic surgeons,  who go directly from laparotomy to robotic surgery are potentially dangerous when complications occur since they they will have to do a laparotomy losing time which might be crucial.

Prof P.R. Koninckx and Drssa A. Ussia

L’endometrio nelle donne con endometriosi superficiale è piu innervato. In tanti siti blog è riportato  che ciò può essere utile come test per fare una diagnosi di endometriosi.

Our Comments

This is another example (as I discussed in http://www.gynsurgery.be and http://www.mondoginecologico.it) that interpretation of research data should be done carefully and that conclusions by researchers often are overstretched and/or biased.
The observation of higher incidences of nerve fibers in the endometrium of women with endometriosis is nice research. To suggest this as a non invasive diagnostic test however is way premature.
1. First, an association does not permit to conclude about cause and effect. We know ( more than 50 articles) since 20 years that the endometrium of women with endometriosis is slightly different from the endometrium of women without endometriosis. It is unclear whether these differences are a consequence of the endometriosis or whether these differences merely signal an ‘endometrioitic’ constitution (as suggested in the endometriotic disease theory). Knowing what happens after surgical excision of endometriosis could give a hint. We previously demonstrated that the decrease in natural killer cells in endometriosis women is not affected by surgical excision of endometriosis whereas CA125 decreases tremendously therafter.
2. Second the article knowingly and willingly disregard subtle endometriosis which is present intermittently in many women and which -I and others think- should not be considered a disease, as discussed in the literature since more than 10 years.
My guess considering the pain symptoms, is that the increased nerve endings is a sign besides many others, that a women will have more retrograde menstruation and also more frequently subtle endometriosis etc, something I am considering since many years as irrelevant findings at laparoscopy since subtle endometriosis does not cause pain or infertility.
The key problem of not recognising or not referring severe endometriosis or doing an incomplete excision or doing unnecessary bowel resections will remain.

The key problem for women with endometriosis will remain the same : not recognising or not referring severe endometriosis or doing an incomplete excision or doing unnecessary bowel resections. The risk is that this observation will be used before proper validation and that it will result in a lot of unnecessary laparoscopies and surgery.
Prof P. R. Koninckx and Dr A. Ussia